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CD133+ Autologous Cells After Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00400959
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : November 17, 2006
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:

TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.

TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.

SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).


  1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
  2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.


  3. To evaluate the disease-related morbility of the target population.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: cd133+cell intracoronary administration Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
Study Start Date : June 2004
Estimated Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Primary Outcome Measures :
  1. myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
  2. Ejection fraction (%) evaluated by 2D echocardiography;

Secondary Outcome Measures :
  1. perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
  2. Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent;
  • age: 18-65 years;
  • large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
  • signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van’t Hof et al., Circulation, 1998); life expectancy more than 6 months.

Exclusion Criteria:

  • Pregnancy;
  • indication to aorto-coronaric by-pass;
  • neoplasia (previous or in progress);
  • primary diseases of the BM;
  • diabetes;
  • immunosuppressive therapy;
  • laboratory alterations of protein S, protein C, ATIII or Fibrinogen;
  • severe co-morbidity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400959

Cell Factory, department of regenerative medicine, Policlinic of Milan
Milan, Italy
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator: Rosaria Giordano, MD Cell Factory Department of Regenerative Medicine Policlinic Milan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00400959     History of Changes
Other Study ID Numbers: CFT92002
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: November 17, 2006
Last Verified: November 2006

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
cell therapy
acute myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases